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Last Updated: May 26, 2022

QSYMIA Drug Patent Profile


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When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch® Generic Entry Outlook for Qsymia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 9, 2028. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for QSYMIA
Drug Prices for QSYMIA

See drug prices for QSYMIA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VIVUS LLCPhase 4
University of MinnesotaPhase 2
The Cleveland ClinicPhase 4

See all QSYMIA clinical trials

Paragraph IV (Patent) Challenges for QSYMIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QSYMIA Extended-release Capsules phentermine hydrochloride; topiramate 3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg 022580 1 2013-07-18

US Patents and Regulatory Information for QSYMIA

QSYMIA is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QSYMIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QSYMIA

Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT

Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT

Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 See Plans and Pricing See Plans and Pricing
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 See Plans and Pricing See Plans and Pricing
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09257572
Estimated Expiration: See Plans and Pricing

Patent: 09257573
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0914985
Estimated Expiration: See Plans and Pricing

Patent: 0914991
Estimated Expiration: See Plans and Pricing

Canada

Patent: 27313
Estimated Expiration: See Plans and Pricing

Patent: 27319
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10001365
Estimated Expiration: See Plans and Pricing

Patent: 10001366
Estimated Expiration: See Plans and Pricing

China

Patent: 2112126
Estimated Expiration: See Plans and Pricing

Patent: 2112127
Estimated Expiration: See Plans and Pricing

Patent: 4825477
Estimated Expiration: See Plans and Pricing

Patent: 5534921
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18103
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 17997
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 00002
Estimated Expiration: See Plans and Pricing

Patent: 17997
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 13489
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9874
Estimated Expiration: See Plans and Pricing

Patent: 9875
Estimated Expiration: See Plans and Pricing

Japan

Patent: 52595
Estimated Expiration: See Plans and Pricing

Patent: 77053
Estimated Expiration: See Plans and Pricing

Patent: 14750
Estimated Expiration: See Plans and Pricing

Patent: 11522896
Estimated Expiration: See Plans and Pricing

Patent: 11522897
Estimated Expiration: See Plans and Pricing

Patent: 15166380
Estimated Expiration: See Plans and Pricing

Patent: 16006085
Estimated Expiration: See Plans and Pricing

Patent: 17078083
Estimated Expiration: See Plans and Pricing

Patent: 17105788
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2684
Estimated Expiration: See Plans and Pricing

Patent: 10013503
Estimated Expiration: See Plans and Pricing

Patent: 10013505
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 17997
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1008839
Estimated Expiration: See Plans and Pricing

Patent: 1008840
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 110042280
Estimated Expiration: See Plans and Pricing

Patent: 110044847
Estimated Expiration: See Plans and Pricing

Patent: 140121491
Estimated Expiration: See Plans and Pricing

Spain

Patent: 06041
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country Patent Number Title Estimated Expiration
South Africa 201008840 ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY See Plans and Pricing
Norway 317754 See Plans and Pricing
Spain 2184127 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QSYMIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 CA 2021 00049 Denmark See Plans and Pricing PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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McKinsey
Baxter
Johnson and Johnson
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.